Science & Pharmaceutical JobsMDR Labeling Compliance Lead

  • CJ50472
  • Temporary/Contract
  • Waterford

Collins McNicholas

MDR Labeling Compliance Lead | Waterford |

Role Responsibilities:

  • Develop MDR Labeling Compliance requirements for all sites within scope of the project.
  • Create a strategy for the implementation of MDR requirements.
  • Liaise with cross functional teams on the strategy.
  • Communicate with stakeholders ensuring acceptance of labeling changes in regions outside EU who accept CE marked product.
  • Project management of the MDR Labeling Compliance deliverables.
  • Perform gap assessment against the required standards for the labelling portfolio for products.
  • Remediate gaps for labelling
  • Work with cross functional site teams on the implementation of labeling requirements for all products within scope.
  • Ontime delivery of the schedule.
  • Change management activities for the implementation of MDR labeling requirements.
  • Other duties as assigned by CL MDR project lead

 

Requirements:

  • Third level Qualification in Science or Engineering
  • Knowledge of labelling regulations
  • Previous experience of implementing labelling/packaging changes
  • New product introduction (is an advantage)
  • Cross functional project team management
  • Working Knowledge of MS project
  • Working knowledge of change management systems/processes.
  • Experience project manager
  • Working knowledge of packaging and labelling processes
  • Working knowledge of global QMS systems (e.g. document and change management systems)
  • Good communication skills ( verbal & written )
  • Decisive, self-motivated/capable of working on own initiative, and able to prioritise and a proactive approach.
  • High attention to detail
  • Medical Device or Pharmaceutical experience
  • CGMP

For a confidential discussion and more information on the role, please contact Aisling Lane.

aisling.lane@collinsmcnicholas.ie

021-4320675

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